Genetic engineering is a technical process and as such it is subject to specific rules and regulations that are designed so as to ensure proper technical, ecological and economical environments for the process itself and for the resulting products. Such rules are well established in other fields of technology and, among other purposes, are intended to ensure high quality and reproducibility of the process and resulting products, and to protect the general public, consumers, producers, as well as the environment. Genetically modified (GM) organisms are special products created by humans in that they are self-replicating. Thus, any transgenic material released into the environment has a potential of persisting for a very long time. The scientific community is often accused of being overly fascinated by scientific discovery and recklessly endangering public health and environment by advocating early release of genetically modified organisms, such as GM plants. Since 1994, some 3.5 trillion transgenic plants have been grown in the Americas, and no evidence of ill effects was found. Still, ‘good technology practices’ concerning the process of genetic manipulation and the transgenic organisms as products are far from being mature, and further efforts should be conducted. One such element of more advanced biotechnological processes is providing proper technical information data, including labeling and registration of the products.
Several groups have advocated to label food products containing GM organisms (GMOs). The recent decision of the European Union to curb the moratorium on transgenic plants is a positive move in the right direction (Schiermeier, Q. 2001, Nature, 409, 967-968). However, the states which are de facto behind the moratorium called for additional rules on the tracebility and labeling of GM products.
The labelling of objects including liquid and solid materials, valuable objects etc. with nucleic acid fragments has been disclosed in a number of patents/patent applications (see WO9014441; EP408-424; WO9117265; WO9404918; WO9416902). Two patent applications (WO9617954; WO0059917) claim, in addition to non-living objects, the use of DNA/biopolymers for labelling living objects. However, these publications do not provide the teaching of a secure labeling with regard to transgenic organisms. In particular transgenic plants and animals were genetically engineered in such a way as to separate the functional and technical (informational) part of the DNA insert on a host chromosome. The prior art labelling method does neither address the problem of losing the label during multiple reproductions of the GMO nor the problem of a high frequency of loss or corruption of the information content of the label.
It is therefore a problem of this invention to provide methods which allow an unambiguous and secure genetic labelling of GMOs.
It is another problem of the invention to provide methods which allow the tracing of transgenes and GM organisms released into the environment and products derived therefrom.